Singapore - English - HSA (Health Sciences Authority)

ascensia diabetes care singapore private limited - clinical chemistry - it is intended for self-testing by persons with diabetes and health care professionals in venous blood and in fresh capillary whole blood drawn from the fingertip or palm. the contour diabetes app is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. it should not be used for the diagnosis of or screening for diabetes or for neonatal use. the system is intended for in vitro diagnostic use only.

Singapore - English - HSA (Health Sciences Authority)

ascensia diabetes care singapore private limited - clinical chemistry - contour care blood glucose monitoring system is intended to be used for the measurement of blood glucose in both insulin and non-insulin treated patients with diabetes as an aid for patients and their health care professionals in monitoring the effectiveness of the patient’s diabetes control. it is intended for self-testing by persons with diabetes and health care professionals in venous blood and in fresh capillary whole blood drawn from the fingertip or palm. it should not be used for the diagnosis of or screening for diabetes or for neonatal use. alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). the contour care test strips are for use with the contour care blood glucose meter to quantitatively measure glucose in venous blood and fresh capillary whole blood drawn from the fingertips or palm. the system is intended for in vitro diagnostic use only.

Singapore - English - HSA (Health Sciences Authority)

ascensia diabetes care singapore private limited - clinical chemistry - the contour®plus elite blood glucose monitoring system is intended to be used for the measurement of blood glucose in both insulin and non-insulin treated patients with diabetes as an aid for patients and their health care professionals in monitoring the effectiveness of the patient’s diabetes control. it is intended for self-testing by persons with diabetes and health care professionals in venous blood and in fresh capillary whole blood drawn from the fingertip or palm. it should not be used for the diagnosis of or screening for diabetes or for neonatal use. alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). the contour®plus test strips are for use with the contour®plus elite blood glucose meter to quantitatively measure glucose in venous blood and fresh capillary whole blood drawn from the fingertips or palm. the system is intended for in vitro diagnostic use only.

Australia - English - Department of Health (Therapeutic Goods Administration)

ascensia diabetes care australia pty ltd - 30854 - glucose monitoring system ivd, home-use/point-of-care - the system is used for the measurement of glucose in whole blood. the system is a device used by persons with diabetes in home settings and by healthcare professionals in healthcare facilities. it is to be used with contour test strips and control solutions that will be supplied separately.

Australia - English - Department of Health (Therapeutic Goods Administration)

ascensia diabetes care australia pty ltd - 58884 - self-care monitoring web-based application software - a diabetes management computer application program intended for use by health care professionals and patients with diabetes for reviewing and printing reports. these reports display the meter readings from compatible meters.

Singapore - English - HSA (Health Sciences Authority)

ascensia diabetes care singapore private limited - clinical chemistry - it is intended for self-testing by persons with diabetes and by healthcare professionals to monitor glucose concentrations in venous whole blood and in fresh capillary whole blood drawn from the fingertip or palm, arterial and venous whole blood or neonatal blood. it is for quantitative measurement of glucose in whole blood from 0.6 mmol/l to 33.3 mmol/l.

Singapore - English - HSA (Health Sciences Authority)

ascensia diabetes care singapore private limited - clinical chemistry - the contour plus link 2.4 wireless blood glucose monitoring system (meter, test strips and control solution) is intended for self-testing by persons with diabetes to monitor gluocse concentrations for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertip or palm. it is intended for in vitro diagnostic use only. the clinical utility of this device is that it may be used as an aid to monitor the effectiveness of a diabetes control program. the contour plus link 2.4 wireless blood glucose monitoring system is intended to be used to transmit glucose values and send a remote bolus to medtronic devices and facilitate transfer of information to medtronic carelink software through use of radio frequency communication. the contour plus link 2.4 wireless blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and it is not intended for use on neonates.

Singapore - English - HSA (Health Sciences Authority)

ascensia diabetes care singapore private limited - clinical chemistry - the contour ts system (meter, test strips, controls) is intended for self-testing by people with diabetes and by healthcare professionals to monitor glucose concentrations in whole blood

Singapore - English - HSA (Health Sciences Authority)

ascensia diabetes care singapore private limited - clinical chemistry - diastix® reagent strips are intended for self-testing by persons with diabetes and by healthcare professionals to monitor the level of glucose in urine. the reagent strip is specific for glucose and can only be used to determine the amount of glucose in urine.

Singapore - English - HSA (Health Sciences Authority)

ascensia diabetes care singapore private limited - general hospital - the microlet next lancing device is designed for self-testing by a single patient.